1. The Field of the Invention
The present disclosure generally relates to tissue closure apparatuses and methods.
2. The Relevant Technology
During intravascular and other related medical procedures, catheters are typically inserted through an incision or puncture in the skin and underlying tissues to access an artery or vein, typically in the groin, neck, or subclavian areas of a patient. The catheter can be inserted through a puncture in the blood vessel and guided to the desired site to perform interventional procedures such as angiography, angioplasty, stent delivery, plaque removal, and infusion of a therapeutic substance.
After the procedure is completed and the catheter is removed from the patient, however, the access hole must be closed to prevent hemorrhage. This is typically achieved by applying pressure over the blood vessel manually and then by applying a pressure bandage or a compressive weight. With conventional methods, the risk of post-puncture hemorrhage is high, which can cause considerable complications. The risk of complications is exacerbated by the concomitant use of anticoagulant medications such as heparin or warfarin and by anti-platelet drugs, which are commonly used following a procedure in order to prevent clot formation and thrombus and/or to treat vascular disease.
It is generally recognized that many currently employed vascular sealing methods and devices and other tissue closure methods and devices incompletely seal holes or wounds in vascular or other tissue. Achieving complete wound closure is particularly important in sealing arterial punctures, which are relatively high pressure systems. For example, under normal blood pressure, the arterial system has a pressure of about 120/80 mmHg or more. Failure to completely close arterial holes can result in hematoma, exsanguination, and in extreme cases, may result in catastrophic consequences, such as limb amputation and death. Moreover, many currently employed vascular devices employ methods and materials that remain on the intravascular endothelial surface or otherwise in the sealed vessel. Materials that remain intravascularly can be a nidus for thrombus or intravascular mural hyperplasia with later spontaneous and catastrophic closure of the vessel.
To overcome these shortcomings, some currently employed vascular devices seal the vessel from the outside of the vessel. However, these vascular devices are typically made of stainless steel, titanium, nickel-titanium (Nitinol) or other non-bioabsorbable material. As such, these vascular devices will permanently remain within the body unless physically removed later by a physician. With a prevalence of reaccessing patients for multiple procedures, this can lead to various problems. For example, when a physician tries to reenter the blood vessel in the same location, the prior placed vascular device will prevent the physician from doing so, and could possibly cause damage to the insertion instrument being used. Furthermore, after each procedure, an additional vascular device will be attached to the blood vessel to be left permanently in the body.